Latest Biotech News

FDA and industry negotiated the next Prescription Drug User Fee Act (PDUFA) VIII commitment letter, setting review goals for 2028–2032 with themes of stability, transparency and “maturity,”...

Regenerxbio’s Hunter syndrome gene therapy (RGX-121, clemidsogene lanparvovec) ran into a new safety roadblock as the FDA placed another clinical hold after masses were detected on the spines of...

Capricor Therapeutics said the FDA extended its review of deramiocel (the company’s Duchenne muscular dystrophy cell therapy candidate) after a negative advisory committee vote, pushing further...

Cellares, a cell therapy manufacturing specialist, announced plans to lay off 100 employees after an unnamed large pharmaceutical customer terminated a contract, according to CEO Fabian...

Roche added to its obesity portfolio by licensing Hanmi Pharmaceutical’s early-stage urocortin-2 analog HM-17321, agreeing to pay $190 million up front with potential total payments of up to $2.3...

A multicenter, open-label phase trial reported promise for an unresectable hepatocellular carcinoma regimen combining cadonilimab with lenvatinib and TACE (transarterial chemoembolization). The...

A new analysis of multiple myeloma clinical trials from 2014 to 2024 found CAR-T therapies now dominate pipeline activity, representing 46.8% of studies listed on ClinicalTrials.gov and in...

Roche and Eli Lilly received U.S. FDA clearance for the Elecsys Phospho-Tau (217P) Plasma test, a blood-based assay intended to identify amyloid pathology associated with Alzheimer’s. The cleared...

A Delaware federal court ordered Guardant Health to pay roughly $245 million in damages, royalties and interest to TwinStrand Biosciences and the University of Washington for duplex sequencing...

WHO opened a prequalification pathway for interferon gamma release assays (IGRAs) and targeted next-generation sequencing (tNGS)-based in vitro tuberculosis diagnostics, enabling independent...

Roche and Eli Lilly won U.S. FDA clearance for the Elecsys Phospho-Tau (217P) Plasma blood test, designed to detect amyloid pathology tied to Alzheimer’s disease. The assay is intended for people...

Regenerxbio’s Hunter syndrome gene therapy programs hit another regulatory snag, with the FDA placing clinical holds tied to asymptomatic spine MRI findings. The company said it no longer expects...

A new systematic review and meta-analysis of phase III trials suggests menopause status can change outcomes with adjuvant CDK4/6 inhibitors in early hormone-receptor-positive breast cancer. The...

Moderna and Merck reported positive Phase 3 topline results for their mRNA cancer vaccine intismeran autogene in an individualized neoantigen therapy regimen. In the INTerpath-001 study (1,137...

Roche agreed to license Hanmi Pharmaceutical’s early-stage obesity candidate HM-17321, part of a strategy to drive weight loss while preserving muscle. The deal reportedly includes $190 million...

Researchers reported an mRNA delivery system designed to generate functional CAR T cells inside the body, removing the need for external immune stimulation or antibody targeting. Using...

FDA extended review timelines for Capricor Therapeutics’ deramiocel, delaying the PDUFA decision as the agency requests additional data for a more focused indication. The update follows earlier...

WHO opened its prequalification pathway for interferon gamma release assays and targeted next-generation sequencing (tNGS)-based tuberculosis in vitro diagnostics. The move is intended to support...

An analysis of multiple myeloma clinical trials from 2014–2024 finds CAR-T therapies now represent nearly half of studies, highlighting a pipeline realignment toward cell-based...

Researchers tested whether multiplex PCR can guide antibiotic decisions in ventilated patients with suspected hospital-acquired pneumonia, a high-stakes area where diagnostic uncertainty drives...